At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com

Job Function:

R& D Operations

Job Sub Function:

Clinical Trial Support

Job Category:

People Leader

All Job Posting Locations:

Belgrade, Central Serbia, Serbia, Berlin, Germany, Budapest, Hungary, Galway, Ireland, Iasi, Iasi, Romania, Istanbul, Turkey, Kiev, Kyiv, Ukraine, Kraków, Malopolskie, Poland, Ljubljana, Slovenia, Madrid, Spain, Milano, Italy, Oslo, Norway, Ostrava, Moravskoslezsky kraj, Czech Republic, Paris, Île-de-France, France, Pefki, Attiki, Greece, Riga, Rīga, Latvia, RU037 Synthes Russia, Selzach, Switzerland, Sofia, Bulgaria, Stockholm, Stockholm, Sweden, Tallinn, Harju, Estonia, Vienna, Austria, Vilnius, Vilniaus Apskritis, Lithuania

Job Description:

The Scientific Operations (SciOps) Associate Director, will provide strategic oversight and governance to related functions ensuring the delivery of key regulatory and medical documents. Specifically, the Associate Director will lead the strategy and execution of Clinical Evaluations (CERs), State of the Art Assessments (SOA), Literature Reviews, Summaries of Safety and Clinical Performance (SSCP), and Periodic Safety Updates (PSUR) for the MedTech Neurovascular business unit. Furthermore, the Associate Director will lead interactions with the Notified Body and applicable Health Authorities and the drafting and alignment on response strategy and execution.

You will lead a diverse team of managers and medical writers based globally and will ensure the identification and retention of high potential individuals through active engagement, motivation, employee development, and promotion. You will provide leadership and maintain relationships through extensive partnering, benchmarking, and forming strategic alliances with cross functional business partners to drive key business goals and objectives. Additionally, you will lead SciOps activities supporting the Eudamed Readiness strategies for SSCP and PSURs in support of the EU MDR.

Responsibilities:

• Lead a team of managers and medical writers to strategize, synthesize and analyze product related safety and performance data, draft reports, coordinate approvals, and when applicable manage submissions to the Notified Body.
• Partner with R& D, Medical Affairs, Clinical, and Regulatory in the establishment of appropriate routes of conformity for clinical evaluations for new products introductions and product design changes and ensure robust data sufficiency strategies.
• Develop and track performance and compliance metrics providing visibility to progress and rising challenges, enabling risk mitigation, corrective and preventive action to be taken as needed.
• Track and trend Notified Body inquiries within business unit to identify trends, improve processes, and increase speed to market. Translate insights into viable processes and solutions that create value.
• Be a member of the MedTech Scientific Operations SOP committee responsible for the effective optimization and harmonization of processes across all MedTech franchises, supporting gap assessments against new regulations, and facilitating implementation plans.
• Generate materials, lead workshops, and deliver training to ensure adequate implementation of guidelines and contribute to the professional development of employees.
• Manage budget and all financial business processes.

Qualifications

Required:

• Minimum of a Bachelor’s degree (University Degree), in Life Sciences, Engineering or related subject area.
• Minimum of 8 years of experience in a regulated environment including five years of direct experience with medical devices in the fields of technical or medical writing, post market surveillance, clinical research, or product risk management.
• Minimum of 2 years of people leadership experience.

Preferred:

• Knowledge on physiology and common outcomes of neurovascular diseases and events
• An advanced degree, MS, PhD, RN, or MBA.
• Process Excellence / Six Sigma training or certifications.